Permian Health Women's Lung Health Study (NCT06029543) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Permian Health Women's Lung Health Study
The Gambia350 participantsStarted 2023-12
Plain-language summary
The goal of this cross-sectional observational study is to estimate the prevalence of lung function impairment as measured by spirometry in a population of Gambian women aged 15 and older. The main question\[s\] it aims to answer are:
* What is the prevalence of lung function impairment in Gambian women
* What is the prevalence of eosinophilic inflammation in Gambian women
Consenting participants will undergo
* Spirometry
* Fractional exhaled nitric oxide (FENO) testing
* α1-antitrypsin testing in patients with lung function impairment as assessed by spirometry
Who can participate
Age range
15 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Self-identified female sex
* Age \> 15 years: This age cutoff was chosen (as opposed to 18) because of the unique cultural norms and practices in the country where experiences and exposures occur at an earlier age than women in Western countries.
Exclusion criteria:
* Age \< 15 years
* Non-resident household member
* Any acutely unwell individual
* Pregnancy
* Any known history of active pulmonary disease (including TB) on treatment.
* Individuals unable or unwilling to give consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of lung function Impairment as measured by spirometry
Timeframe: Through study completion, an average of 1 year